Using Probiotics to Improve Oral Hygiene During Orthodontic Treatment

Not Applicable

Completed

• Conditions: Orthodontic Appliance Complication
• Interventions: Drug: Probiotics; Procedure: Traditional treatment

• Registration Number: NCT06641960
• Lead Sponsor: Damascus University

Brief Summary

Fifty patients needing non-extraction-based metallic orthodontic treatment will be divided randomly into the probiotic group and the control group. In each group, they will brush their teeth regularly while receiving orthodontic treatment. Only the probiotic group will take probiotic tablets for six months.

Clinical parameters will be assessed before and during orthodontic treatment and after 3 and 6 months during treatment.

Detailed Description

Each subject will be examined completely to ensure eligibility before enrolling in the study. The operator will then inform them about the study's aim and ask them to provide written informed consent. Patients will receive professional scaling, polishing, and oral hygiene instruction before the research starts.

Regarding the probiotic, (PRODENTIS) is commercially available in Sweden and the USA. Probiotics prepared by Bio-Gaia AB (Stockholm, Sweden). Each probiotic tablet contains two strains of probiotic lactic acid bacteria of human origin: L. reuteri DSM 17938 and L. reuteri ATCC (PTA 5289), each at a minimum of 1 × 108 CFU per lozenge. The tablets should be stored at a temperature below 25 ◦C. Dosage instructions will be prescribed per the manufacturer's recommendations at a preventive dosage of 1 lozenge/day (after dinner and teeth brushing).

Regarding the clinical parameters, the Plaque index (Pl), the gingival index (GI), the Papillary Bleeding Index (PBI), 1977, and probing depth (PD) will be evaluated.

Study Timeline

• Study Start: 2023-03-05
• Primary Completion: 2023-08-06
• Study Completion: 2024-06-17
• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult healthy male and female patients aged 18-25 years.

2. Patients eligible for full arch upper and lower fixed labial orthodontic appliance treatment and molar band.

3. Patients with malocclusion class I, II, or III without crowding on the anterior teeth.

4. Permanent occlusion and existence of all the upper and lower teeth (except third molars).

5. Good oral and periodontal health:

   • Probing depth < 4 mm
   • No radiographic evidence of bone loss.
   • Gingival index ≤ 1
   • Plaque index ≤ 1

Read More

Exclusion Criteria

1. Previous orthodontic treatment history.
2. Patients with any systemic disorder that could influence periodontal conditions or response to treatment (such as hypertension, diabetes, or immunological disorders).
3. Patients were on systemic drugs, i.e., antibiotics, hypertensives, analgesics, hormonal drugs, sedatives, and anti-seizure medication, within three months before the baseline examination.
4. Patients who were allergic to ingredients of the probiotics lozenges.
5. Those undergoing periodontal treatment within three months before the baseline examination.
6. Smokers, pregnant or lactating women.
7. Regular use of antibacterial mouthwash.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics group	Probiotics	In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction with probiotic lozenges.
The control group without Probiotics	Traditional treatment	In this group, the patients will undergo orthodontic treatment with metallic appliances and receive oral hygiene instruction without probiotic lozenges.

Primary Outcome Measures

Name	Time	Method
The change in the plaque index	Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months	Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for plaque index are as follows: 0. No plaque; 1. A film of plaque adheres to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after the application of the disclosing solution or by using a probe on the tooth surface.; 2. Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye.; 3. An abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.
The change in the gingival index	Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months	Assessment will be achieved using a gingival probe, according to Silness and Loe (1964). The criteria for the gingival index are as follows: 0. Normal gingiva.; 1. Mild inflammation: a slight change in color, slight edema, no bleeding on probing.; 2. Moderate inflammation: moderate glazing, redness, edema, hypertrophy, bleeding on probing.; 3. Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding.
The change in papillary bleeding index	Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months	Assessment will be achieved using a gingival probe, according to Muhlemann (1977).; 0. No bleeding.; 1. A single discreet bleeding point appears.; 2. Several isolated bleeding points or a single fine line of blood appear.; 3. The interdental triangle fills with blood shortly after probing.; 4. Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
The change in the probing depth	Time Frame: T0: immediately before applying the fixed appliance; T1: at three months; T2: at six months	Assessment will be achieved using a gingival probe, according to Bowers (1964). It will be measured clinically as the distance from the free gingival margin to the gingival sulcus. The reading of PD ≤3 mm was considered normal, while any reading \>3 mm was considered a gingival pocket

Trial Locations

Locations (1)

Department of Orthodontics, Faculty of Dentistry, University of Damsacus; 🇸🇾 Damascus, Syrian Arab Republic